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METHOD AND COMPOSITION FOR REDUCING AGREGATION OF MACROMOLECULES UNDER PHYSIOLOGICAL CONDITIONS
专利权人:
ДЖЕНЕНТЕК, ИНК.
发明人:
ЛОБО Брайан,ЛО Сабрина,ВАНГ Ючанг Джон,ВОНГ Рита
申请号:
RU2011124550
公开号:
RU2011124550A
申请日:
2009.11.16
申请国别(地区):
RU
年份:
2012
代理人:
摘要:
1. A method of minimizing inflammation at the injection site during subcutaneous administration of a macromolecule, comprising adding from 2% to 30% cyclodextrin to a composition containing said macromolecule. The method according to claim 1, wherein the cyclodextrin is selected from the group consisting of HP-beta-cyclodextrin, HP-gamma-cyclodextrin and SBE-cyclodextrin. The method according to claim 2, wherein said composition comprises from 5% to 30% HP-beta-cyclodextrin or HP-gamma-cyclodextrin. The method according to claim 3, wherein said composition comprises from 5% to 30% HP-beta-cyclodextrin. The method according to claim 3, wherein said composition contains from 5% to 20% HP-gamma-cyclodextrin. The method according to claim 5, wherein said composition further comprises from 50 mM to 200 mM arginine succinate. The method according to claim 2, wherein said composition contains from 2% to 9% SBE-cyclodextrin. The method according to claim 1, wherein said macromolecule is a protein. The method of claim 8, wherein said protein is an antibody. The method of claim 9, wherein said antibody is a therapeutic antibody. The method of claim 9, wherein said antibody is a diagnostic antibody. The method of claim 9, wherein said antibody is an anti-CD20 antibody. The method of claim 12, wherein said antibody comprises an A, B, C, D, F, G, H, or I antibody variant, as shown in Table 1.14. The method of claim 12, wherein said antibody comprises an amino acid sequence selected from the group consisting of SEQ ID NO: 1-15.15. The method of claim 12, wherein said antibody comprises a light chain variable domain of SEQ ID NO: 1 and a heavy chain variable domain of SEQ ID NO: 2.16. The method of claim 12, wherein said antibody comprises a light variable domain �1. Способ минимизации воспаления в месте инъекции в процессе подкожного введения макромолекулы, предусматривающий добавление к композиции, содержащей указанную макромолекулу, от 2% до 30% циклодекстрина.2. Способ по п.1,
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